The Recall Desk

Manufacturer

Ossur Americas

12 recalls in our database name Ossur Americas as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
0
Severe
0
Most recent
2022-10-05

Of the 12 recalls from Ossur Americas we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–12 of 12

  • HighFDA (Devices)·Z-1821-2022·2022-10-05

    OSSUR Power Knee Prosthetics Recalled for Battery Dislodgement Risk

    OSSUR Power Knee prosthetics are being recalled because the battery may dislodge from the device. Approximately 190 units are affected across the United States.

    Product
    OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2022·2022-07-13

    Ossur Variflex Suba Junior prosthetic foot may crack under impact

    Ossur has recalled 410 Variflex Suba Junior prosthetic feet due to cracking and breaking under impact stress. The device is designed for children and adolescents worldwide.

    Product
    OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2022·2021-12-22

    FDA Updates Instructions for Miami J Select Collar Device

    Ossur Americas is updating instructions for the Miami J Select Collar (MJS-101) and Miami J Select Collar Set (MJSR-101) to provide additional guidance on device selection and proper use nationwide.

    Product
    Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1896-2021·2021-06-23

    OSSUR Miami J Select Collar Recalled for Deforming Height-Adjustment Racks

    Ossur Americas is recalling the MIAMI J SELECT COLLAR cervical spine device due to deforming racks that may reduce immobilization. About 10,469 units were distributed nationwide.

    Product
    OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0997-2019·2019-03-20

    Ossur Skull Pin Recall Due to Labeling Error and Safety Testing

    Ossur Americas is recalling 372 sterile titanium skull pins because the label incorrectly lists a ceramic tip and the products require confirmatory safety testing.

    Product
    Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK; 520TS/ Skull Pin 2-1/4in TI Sterl 5PK; 520V2S/ Skull Pin 3in TI Sterl 5 PK
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1000-2019·2019-03-20

    Ossur CB Resolve Halo System Recalled for Labeling and Testing Issues

    Ossur Americas is recalling 656 units of CB Resolve Halo system products due to a labeling error and the need for confirmatory safety testing.

    Product
    Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ CB RESOLVE STERILE UNIT STD; 505500C/ CB Resolve Sterile Unit LRG; 515300C/ CB RESOLVE RING KIT SM-No App; 515400C/ CB RESOLVE RING KIT STD-No App; 515500C/ CB RESOLVE RING KIT
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1001-2019·2019-03-20

    Ossur Halo System Ring Kits Recalled for Labeling and Safety Testing

    Ossur Americas is recalling 182 units of Halo system ring kits due to a labeling error and the need for confirmatory safety testing.

    Product
    Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT TI SM; 505400T/ CB RING KIT TI STD; 505400V2/ OB V2 RING KIT TI STD; 505500T/ CB RING KIT TI LG; 505500V2/ OB V2 RING KIT TI LG; 515300V2/ OB V2 RING KIT TI SM-No App; 515400V2/ OB
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-0999-2019·2019-03-20

    Ossur OB Resolve Sterile Ring Kits Recalled for Labeling Errors

    Ossur Americas is recalling 342 units of OB Resolve sterile ring kits due to a labeling error on titanium pins and pending safety testing.

    Product
    Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OB RESOLVE RING KIT STD; 505500D/ OB RESOLVE RING KIT LRG; 515300D/ OB RESOLVE RING KIT SM-No App; 515400D/ OB RESOLVE RING KIT STD-No App; 515500D/ OB RESOLVE RING KIT LG-No Ap
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1003-2019·2019-03-20

    Ossur ReSolve Halo Vest Recalled for Labeling and Safety Testing Issues

    Ossur Americas is recalling 381 ReSolve Halo Vests because the titanium pin label incorrectly lists a ceramic tip and the products require confirmatory safety testing.

    Product
    Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo Vest-shrt lmbwool; 545800K/ ReSolve Halo Vest-tall kodel; 545800L/ ReSolve Halo Vest-tall lmbwool
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1004-2019·2019-03-20

    Ossur LIL Angel Vest Recalled for Labeling and Safety Testing Issues

    Ossur Americas is recalling 45 LIL Angel Vests because the titanium pin labels incorrectly list ceramic tips and require confirmatory safety testing.

    Product
    Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/ LIL ANGEL VEST P2 LAMBSWOOL; 545100S/ LIL ANGEL VEST P2 SORBATEX; 545150K/ LIL ANGEL VEST P3 KODEL; 545150L/ LIL ANGEL VEST P3 LAMBSWOOL; 545150S/ LIL ANGEL VEST P3 SORBATEX
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1002-2019·2019-03-20

    Ossur J Tong Sterile Medical Device Recall for Labeling Error

    Ossur Americas is recalling 138 units of J Tong sterile medical devices because the titanium pin label incorrectly lists a ceramic tip.

    Product
    Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-0998-2019·2019-03-20

    Ossur Skull Pin Recall for Labeling Error and Safety Testing

    Ossur Americas is recalling 824 sterile skull pins due to a label error and pending safety testing.

    Product
    Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK; 516DS/ Skull Pin 3in CT Sterl 1PK; 517CS/ Skull Pin 2-1/4in CT Sterl 4PK; 517DS/ Skull Pin 3in CT Sterl 4 PK; 522CS/ Skull Pin 2-1/4in CT Sterl 6PK; 522C/ SKULL PIN 2-1/4
    Category
    Medical Device
    Distribution
    28 states